Efficacy of Raltegravir in a Large Urban HIV Clinical Population in Milan

This will be a retrospective analysis of efficacy, safety and tolerability of raltegravir as part of an optimized therapy in a clinical setting.

Follow-up is calculated from the treatment initiation (with or without raltegravir) up to the date of discontinuation of the considered regimen or the date of last visit or the date of lost to follow-up, whichever came first.

The Aim of the study is to evaluate the efficacy and safety of raltegravir-containing regimens in a urban clinic setting.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Infectious Diseases Department

Milan, 20127, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects who received raltegravir and were previously exposed to NRTIs, NNRTIs, PIs, regardless of the stage of HIV disease at the start of the treatment.

Exclusion criteria

None

Treatment and study plan

Primary outcomes

Real-Life

Time frame: baseline and week 48

Primary endpoint is the proportion of patients with HIV-1 RNA<50 copies/ml at weeks 48 after treatment initiation (baseline).

Secondary outcomes

Real-Life

Time frame: baseline and week 48
Secondary endpoints are:
- Proportion of patients with HIV-1 RNA<50 copies/ml at the end of the treatment/last available visit
- Proportion of patients with HIV-1 RNA<400 copies/ml at week 48
- Increase in absolute CD4 cell count from baseline
- Frequency of side effects associated with raltegravir treatment
- Frequency of reasons for starting/stopping raltegravir treatment

Sponsors and collaborators

Lead sponsor

Università Vita-Salute San Raffaele

Other

Collaborators

Ospedale San Raffaele

Registry information

Official study title

Efficacy of Raltegravir in a Large Urban HIV Clinic Population in Milan (Efficacy of Raltegravir in a Large Urban HIV Clinic Setting)

Acronym: Real-Life

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Nov 8, 2011
Registry last updated: Feb 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed